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Custom Assemblies Inc recalls Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (
Recalled August 30, 2017 · FDA recall Z-3059-2017 · Custom Assemblies
Hazard
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection. · FDA Class II
Units
2155 kits
Sold at
Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
Description
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Product
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
Manufacturer(s)
Custom Assemblies Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →